CDISC & Clinical Data Standards SMEOffice:Austin
Listed on 2026-08-31
-
IT/Tech
Data Engineering, Information Security & Data Protection, Data Analyst
CDISC & Clinical Data Standards SME
Following our successful expansion into the U.S. and continued growth across Europe, we are seeking a CDISC & Clinical Data Standards SME to help drive our Data function from our Austin hub. This person will play a critical role in making sure every dataset Aika touches is mapped correctly to industry-standard formats, so outputs are trustworthy and submission-ready from day one.
Who We're Looking For:
A true standards specialist - someone whose career has been built around SDTM/ADaM mapping and clinical data standards governance, not just someone who's touched them occasionally. This person should be able to make Biorce's data submission-ready by design, not by clean-up.
Key Responsibilities:
- Own SDTM and ADaM mapping specifications for data flowing through Aika
- Define and maintain clinical data standards governance across the data team
- Review and validate that data structures are submission-ready and audit-defensible
- Partner with Data Engineering and Architecture to embed standards into pipelines by design
- Stay current on CDISC updates and regulatory expectations (FDA/EMA)
- Train and support other team members on standards application
Requirements
Must-haves
- 5+ years as a dedicated CDISC/SDTM/ADaM specialist (standards programming, mapping, or governance)
- Deep, hands-on knowledge of SDTM and ADaM implementation guides
- Experience ensuring submission-readiness for regulatory-facing clinical data
- Excellent attention to detail and documentation discipline
- Excellent written and verbal communication skills in English
Nice-to-Haves
- CDISC certification
- Experience with USDM or protocol digitalisation standards
- Exposure to AI/ML teams translating standards into automated pipelines
Why Join Us?
- A dynamic work environment with an international team, where collaboration and diversity thrive.
- Work alongside top talent, united by a shared purpose and committed to making a real impact.
- Get equipped with a Mac Book to enhance your productivity and work experience.
- Benefits package designed to support you and your family's overall well-being.
- Comprehensive medical, dental, and vision insurance options, effective from your start date or shortly thereafter depending on location.
- Hybrid work model offering flexibility to balance your professional and personal life.
- Company events to celebrate achievements and enjoy time together.
- Our office is pet-friendly! You'll likely be greeted by a few wagging tails upon arrival.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).